Ammonia N-13

AMMONIA N-13- ammonia n-13 injection
Cardinal Health 414, LLC

1 INDICATIONS AND USAGE

Ammonia N-13 Injection, USP is indicated for diagnostic Positron Emission Tomography (PET) imaging of the myocardium under rest or pharmacologic stress conditions to evaluate myocardial perfusion in patients with suspected or existing coronary artery disease.

2 DOSAGE AND ADMINISTRATION

2.1 Rest Imaging Study

Aseptically withdraw Ammonia N-13 Injection, USP from its container and administer 10-20 mCi (0.368 – 0.736 GBq) as a bolus through a catheter inserted into a large peripheral vein.
Start imaging 3 minutes after the injection and acquire images for a total of 10-20 minutes.

2.2 Stress Imaging Study

If a rest imaging study is performed, begin the stress imaging study 40 minutes or more after the first Ammonia N-13 Injection, USP to allow sufficient isotope decay.
Administer a pharmacologic stress-inducing drug in accordance with its labeling.
Aseptically withdraw Ammonia N-13 Injection, USP from its container and administer 10-20 mCi (0.368 – 0.736 GBq) of Ammonia N-13 Injection, USP as a bolus at 8 minutes after the administration of the pharmacologic stress-inducing drug.
Start imaging 3 minutes after the Ammonia N-13 Injection, USP and acquire images for a total of 10-20 minutes.

2.3 Patient Preparation

To increase renal clearance of radioactivity and to minimize radiation dose to the bladder, ensure that the patient is well hydrated before the procedure and encourage voiding as soon as a study is completed and as often as possible thereafter for at least one hour.

2.4 Radiation Dosimetry

The converted radiation absorbed doses in rem/mCi are shown in Table 1. These estimates are calculated from the Task Group of Committee 2 of the International Commission on Radiation Protection.1

Table 1: N-13 Absorbed Radiation Dose Per Unit Activity (rem/mCi) for Adults and Pediatric Groups
* Upper large intestine; ** Lower large intestine

Organ

Adult

15-year old

10-year old

5-year old

1-year old

Adrenals

0.0085

0.0096

0.016

0.025

0.048

Bladder wall

0.030

0.037

0.056

0.089

0.17

Bone surfaces

0.0059

0.0070

0.011

0.019

0.037

Brain

0.016

0.016

0.017

0.019

0.027

Breast

0.0067

0.0067

0.010

0.017

0.033

Stomach wall

0.0063

0.0078

0.012

0.019

0.037

Small intestine

0.0067

0.0081

00013

0.021

0.041

*ULI

0.0067

0.0078

0.013

0.021

0.037

**LLI

0.0070

0.0078

0.013

0.020

0.037

Heart

0.0078

0.0096

0.015

0.023

0.041

Kidneys

0.017

0.021

0.031

0.048

0.089

Liver

0.015

0.018

0.029

0.044

0.085

Lungs

0.0093

0.011

0.018

0.029

0.056

Ovaries

0.0063

0.0085

0.014

0.021

0.041

Pancreas

0.0070

0.0085

0.014

0.021

0.041

Red marrow

0.0063

0.0078

0.012

0.020

0.037

Spleen

0.0093

0.011

0.019

0.030

0.056

Testes

0.0067

0.0070

0.011

0.018

0.035

Thyroid

0.0063

0.0081

0.013

0.021

0.041

Uterus

0.0070

0.0089

0.014

0.023

0.041

Other tissues

0.0059

0.0070

0.011

0.018

0.035

2.5 Drug Handling

Inspect Ammonia N-13 Injection, USP visually for particulate matter and discoloration before administration, whenever solution and container permit.
Do not administer Ammonia N-13 Injection, USP containing particulate matter or discoloration; dispose of these unacceptable or unused preparations in a safe manner, in compliance with applicable regulations.
Wear waterproof gloves and effective shielding when handling Ammonia N-13 Injection, USP.
Use aseptic technique to maintain sterility during all operations involved in the manipulation and administration of Ammonia N-13 Injection, USP. The contents of each vial are sterile and non-pyrogenic.
Use appropriate safety measures, including shielding, consistent with proper patient management to avoid unnecessary radiation exposure to the patient, occupational workers, clinical personnel, and other persons.
Radiopharmaceuticals should be used by or under the control of physicians who are qualified by specific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides.
Before administration of Ammonia N-13 Injection, USP, assay the dose in a properly calibrated dose calibrator.
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